HemaComply Software Maintenance and Support Services

HemaComply Software Maintenance and Support Services Product Service Code:

7A20 NAICS Code:

513210 Place of Performance:

Bethesda, MD 20892, USA POTS: 25-004881 This notice is to inform that it is NOT a request for quotation (RFQ). No solicitation will be issued, and no quotations will be requested.

The National Institutes of Health (NIH), Clinical Center, Office of Purchasing and Contracts, on behalf of the Department of Transfusion Medicine (DTM), intends to award a firm-fixed-price contract on a sole-source basis to Hema Terra Technologies LLC, located at 180 W Ostend Street, Suite 267A, Baltimore, Maryland 21230. The Department of Transfusion Medicine requires ongoing maintenance and support services for HemaComply software applications.

These services will support blood donor operations to ensure compliance with FDA regulations for blood product Quality Assurance/Quality Control (QA/QC) and to function as a recruitment and scheduling system for blood donors. The software is essential for the electronic management of patient and donor records at the NIH.

Hema Terra Technologies will provide maintenance services for the following software products: HemaComply – Lab HemaComply – Equipment Manager HemaControl Additionally, Hema Terra will maintain the existing DTM Donor System. The DTM plays a critical role in the collection of blood and blood components from healthy donors, which are used to treat patients participating in NIH protocols, support biomedical research, and evaluate therapeutic blood product benefits.

Various regulatory bodies, including the FDA and the American Association of Blood Banks (AABB), enforce policies to monitor equipment used in these processes. The Hema Terra software ensures continued compliance by managing electronic records for NIH patients and blood donors. Hema Terra Technologies LLC is the sole provider capable of delivering the required software maintenance and support. Their software meets NIH security standards and integrates with DTM’s existing Blood Bank Computer System (BBCS).

No other vendor can fulfill the specific requirements for continued software support. This acquisition is being conducted under the Federal Acquisition Regulation (FAR) 13.501, which allows for sole-source acquisitions above the Simplified Acquisition Threshold. Contracts awarded under FAR Part 13 are exempt from the competition requirements of FAR Part 6. Interested parties are invited to express their interest and submit capability statements in response to this notice.

The Government reserves the right to determine whether to compete this requirement based on the responses received. All comments or capability statements must reference this posting number and be submitted electronically to Shasheshe Goolsby, Lead Contract Specialist, at shasheshe.goolsby@nih.gov no later than April 30, 2025, by 6:30 AM EST. Please note: This is NOT a request for quotation. Only capability statements will be considered.